Chronic Respiratory DiseaseEarly Phase 1NCT03153800
Autologous Bronchial Basal Cells Transplantation for Treatment of CRD Including COPD, BE and PF
A Early Phase 1 study testing bronchial basal cells in people with Chronic Respiratory Disease, run by Regend Therapeutics at 1 site in China.
Trial summary
Chronic respiratory diseases including chronic obstructive pulmonary disease (COPD), bronchiectasis (BE) or pulmonary fibrosis (PF) are usually not curable with damaged pulmonary structure and function. Bronchial basal cells are proved to regenerate bronchus and alveoli to repair the pulmonary injuries. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Respiratory Disease
- What is being tested?
- bronchial basal cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2017to 4 Oct 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with COPD, BE or PF according to the guideline;
- Clinically stable for more than 4 weeks;
- Tolerant to fiberoptic bronchoscopy test;
- Written informed consent signed.
Who cannot join
- Pregnant or lactating women;
- Patients positive for syphilis, HIV;
- Patients with malignant tumor;
- Patients with serious significant pulmonary infection and need anti-infection treatment;
- Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
- Patients with a history of abusing alcohol and illicit drug;
- Patients participated in other clinical trials in the past 3 months;
- Patients assessed as inappropriate to participate in this clinical trial by investigators.
Trial locations and contacts
1 site in 1 country.
Jianan Huang, M. D. contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hopsital of Soochow University
Suzhou, Jiangsu, 215006
Jianan Huang, M.D., huang_jian_an@163.com
Wei Zuo, Ph. D., zuow@regend.cn
About this study
Official title: Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Respiratory Disease (CRD) Including Chronic Obstructive Pulmonary Disease (COPD), Bronchiectasis (BE) and Pulmonary Fibrosis (PF)
Chronic respiratory diseases including chronic obstructive pulmonary disease (COPD), bronchiectasis (BE) or pulmonary fibrosis (PF) are usually not curable with damaged pulmonary structure and function. Bronchial basal cells are proved to regenerate bronchus and alveoli to repair the pulmonary injuries. In this study, we intend to perform an open, single-armed phase I clinical trial by transplantation of autologous bronchial basal cells on patients suffered from COPD, BE or PF. During the treatment, autologous bronchial basal cells, which were isolated from fiberoptic bronchoscopy and expanded in vitro, will be injected directly into lesions by fiberoptic bronchoscopy after careful characterization. In the following 6 months, the safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.
- Conditions
- Chronic Respiratory Disease
- Being tested
- bronchial basal cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchial basal cellsBiological
Transplantation of autologous bronchial basal cells by fiberoptic bronchoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Bronchial basal cells | Experimental | Not described Receives: Biological: bronchial basal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1)
One of the indicators in pulmonary function test, a marker to assess airway obstruction
Measured: 1-6 months
Diffusion capacity of CO (DLCO)
One of the indicators in pulmonary function test, the extent to which oxygen passes from the air sacs of the lungs into the blood
Measured: 1-6 months
Secondary outcomes (8)
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
One of the indicators in pulmonary function test, representing the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full vital capacity
Measured: 1-6 months
Maximum mid-expiratory flow (MMF)
One of the indicators in pulmonary function test, standing for maximal (mid-)expiratory flow and is the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second
Measured: 1-6 months
Maximum voluntary ventilation (MVV)
One of the indicators in pulmonary function test, measuring the maximum amount of air that can be inhaled and exhaled within one minute
Measured: 1-6 months
Forced vital capacity (FVC)
One of the indicators in pulmonary function test, indicating the maximum amount of air a person can expel from the lungs after a maximum inhalation
Measured: 1-6 months
6-minute-walk test (6MWT)
An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases
Measured: 1-6 months
Modified medical research council (MMRC) chronic dyspnea scale
An indicator to evaluate the level of dyspnea
Measured: 1-6 months
St. George's respiratory questionnaire (SGRQ) scale
A questionnaire to assess life quality affected by the respiratory problems
Measured: 1-6 months
Imaging of lung by high resolution computed tomography (HR-CT)
HR-CT images of lung will be analyzed to indicate the pulmonary structure.
Measured: 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start5 Apr 2017
- Primary completion4 Apr 2021 (estimated)
- Study completion4 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regend Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153800
- Sponsor's protocol ID
- 2017042
- Status last verified
- Sep 2019
- First submitted
- 10 May 2017
- Last updated
- 18 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Respiratory Disease (CRD) Including Chronic Obstructive Pulmonary Disease (COPD), Bronchiectasis (BE) and Pulmonary Fibrosis (PF)
- ClinicalTrials.gov ID
- NCT03153800
- Acronym / sponsor ID
- 2017042
- Conditions
- Chronic Respiratory Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Regend TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 4 Apr 2021 (estimated)
- Study completion
- 4 Oct 2021 (estimated)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic respiratory diseases including chronic obstructive pulmonary disease (COPD), bronchiectasis (BE) or pulmonary fibrosis (PF) are usually not curable with damaged pulmonary structure and function. Bronchial basal cells are proved to regenerate bronchus and alveoli to repair the pulmonary injuries. In this study, we intend to perform an open, single-armed phase I clinical trial by transplantation of autologous bronchial basal cells on patients suffered from COPD, BE or PF. During the treatment, autologous bronchial basal cells, which were isolated from fiberoptic bronchoscopy and expanded in vitro, will be injected directly into lesions by fiberoptic bronchoscopy after careful characterization. In the following 6 months, the safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchial basal cells | Experimental | Biological: bronchial basal cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with COPD, BE or PF according to the guideline;
- Clinically stable for more than 4 weeks;
- Tolerant to fiberoptic bronchoscopy test;
- Written informed consent signed.
Key exclusion criteria (8 listed)
- Pregnant or lactating women;
- Patients positive for syphilis, HIV;
- Patients with malignant tumor;
- Patients with serious significant pulmonary infection and need anti-infection treatment;
- Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchial basal cellsTransplantation of autologous bronchial basal cells by fiberoptic bronchoscopy. | Biological | Bronchial basal cells |
Primary outcome
Forced expiratory volume in one second (FEV1)
Time frame: 1-6 months
One of the indicators in pulmonary function test, a marker to assess airway obstruction
Diffusion capacity of CO (DLCO)
Time frame: 1-6 months
One of the indicators in pulmonary function test, the extent to which oxygen passes from the air sacs of the lungs into the blood
8 secondary outcomes
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
Time frame: 1-6 months
Maximum mid-expiratory flow (MMF)
Time frame: 1-6 months
Maximum voluntary ventilation (MVV)
Time frame: 1-6 months
Forced vital capacity (FVC)
Time frame: 1-6 months
6-minute-walk test (6MWT)
Time frame: 1-6 months
Modified medical research council (MMRC) chronic dyspnea scale
Time frame: 1-6 months
St. George's respiratory questionnaire (SGRQ) scale
Time frame: 1-6 months
Imaging of lung by high resolution computed tomography (HR-CT)
Time frame: 1-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianan Huang, M. D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing bronchial basal cells in people with Chronic Respiratory Disease, run by Regend Therapeutics at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zuo, Ph. D. (086-400-882-1090, zuow@regend.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in one second (FEV1) (time frame: 1-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.